Agency Information Collection Activities: Proposed Collection: Comment Request, 65609-65610 [E8-26271]
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Federal Register / Vol. 73, No. 214 / Tuesday, November 4, 2008 / Notices
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surgically prepared site for the CS must
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–26230 Filed 10–30–08; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
PO 00000
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65609
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Enrollment and ReCertification of Entities in the 340B
Drug Pricing Program (NEW)
Section 602 of Public Law 102–585,
the Veterans Health Care Act of 1992,
enacted section 340B of the Public
Health Service Act (PHS Act)
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities.’’ Section
340B provides that a manufacturer who
sells covered outpatient drugs to eligible
entities must sign a pharmaceutical
pricing agreement with the Secretary of
Health and Human Services in which
the manufacturer agrees to charge a
price for covered outpatient drugs that
will not exceed an amount determined
under a statutory formula.
Covered entities which choose to
participate in the section 340B Drug
Pricing Program must comply with the
requirements of 340B(a)(5) of the PHS
Act. Section 340B(a)(5)(A) prohibits a
covered entity from accepting a
discount for a drug that would also
generate a Medicaid rebate. Further,
section 340B(a)(5)(B) prohibits a
covered entity from reselling or
otherwise transferring a discounted drug
to a person who is not a patient of the
entity.
In response to the statutory mandate
of section 340B(a)(9) to notify
manufacturers of the identities of
covered entities and the mandate of
section 340B(a)(5)(A)(ii) to establish a
mechanism to ensure against duplicate
discounts and the ongoing
E:\FR\FM\04NON1.SGM
04NON1
65610
Federal Register / Vol. 73, No. 214 / Tuesday, November 4, 2008 / Notices
responsibility to administer the 340B
Drug Pricing Program while maintaining
efficiency, transparency and integrity,
the HRSA Office of Pharmacy Affairs
(OPA) developed a process of
registration of covered entities to enable
it to address those mandates.
Enrollment/Registration
To enroll and certify the eligible
federally funded grantees and other
safety net health care providers, OPA
requires entities to submit
administrative information (e.g.,
shipping and billing arrangements,
Medicaid participation), certifying
information and signatures from
appropriate grantee level or entity level
authorizing officials and state/local
government representatives. The
purpose of this registration information
is to determine eligibility for the 340B
program. This information is received
and verified according to 340B
requirements and entered into the 340B
database. Accurate records are critical to
implementation of the 340B legislation
especially to prevent diversion and
duplicate discounts. To maintain
accurate records, the OPA requests
entities to submit modifications to any
administrative information that they
submitted when initially enrolling into
the program. The burden requirement
for these processes is minimal.
Recertification
The purposes of recertification are to
request that 340B covered entities
annually certify program eligibility and
confirm the accuracy of all information
in the covered entity’s 340B database
record. Recertification is an electronic
process that will require the covered
entity to review the current database
record and submit required edits (i.e.,
Number of
respondents
Reporting requirement
Responses
per
respondent
covered entity name and address
changes, changes to 340B designated
contact information, billing and
shipping arrangements). The
recertification process will pose a
minimal burden to 340B covered
entities.
Contract Pharmacy Self-Certification
In order to ensure that drug
manufacturers and drug wholesalers
recognize contract pharmacy
arrangements, covered entities that elect
to utilize a contract pharmacy are
required to submit to OPA a selfcertification form similar to the
registration form that they have signed
an agreement with the contract
pharmacy.
The estimates of annualized burden
are as follows:
Total
responses
Hours per
response
Total burden
hours
DSH & CHILDREN’S HOSPITAL ENROLLMENT, ADDITIONS & RECERTIFICATIONS
340B Program Registrations & Certifications for Disproportionate Share Hospitals ......................................
340B Program Registrations & Certifications for Children’s Hospitals ............................................................
Certifications to Enroll DSH & Children’s Hospitals Outpatient facilities to 340B Program ................................
DSH & Children’s Hospitals’ Annual Recertification ........
70
1
70
.25
17.5
80
1
80
.25
20
180
937
1
1
180
937
.083
.5
14.94
468.5
REGISTRATION FOR ENTITIES OTHER THAN HOSPITALS & RECERTIFICATIONS
340B Registration Form (Family Planning, STD, TB,
and others) ...................................................................
Family Planning Annual Recertification ...........................
STD & TB Annual Recertification ....................................
Other Entity Annual Recertification for entities other
than DSHs, FP, STD or TB entities .............................
Submission of Administrative Changes for any entity .....
170
85
111
1
47
11
170
3995
1221
.083
.083
.083
14.11
331.59
101.34
400
460
10
1
4000
460
.083
.083
332
38.18
166
CONTRACTED PHARMACY SERVICES REGISTRATION & RECERTIFICATIONS
Contracted Pharmacy Services Registration ...................
2000
1
2000
.083
TOTAL ......................................................................
* 4493
........................
13,313
..........................
1504.16
* The total number of respondents may be overestimated since we are unable to avoid duplication of respondents who submit information to
the OPA over the course of participation in the 340B Drug Pricing Program, via the initial registration process to any updates/modifications and
enrolling contract pharmacies, if applicable, to the recertification process.
dwashington3 on PRODPC61 with NOTICES
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: October 28, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–26271 Filed 11–3–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Meeting of the Advisory
Council on Blood Stem Cell
Transplantation
Health Resources and Services
Administration, HHS.
AGENCY:
BILLING CODE 4165–15–P
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15:23 Nov 03, 2008
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Notice of Meeting of the
Advisory Council on Blood Stem Cell
Transplantation.
ACTION:
SUMMARY: Pursuant to Public Law 92–
463, the Federal Advisory Committee
Act, as amended (5 U.S.C. Appendix 2),
notice is hereby given of the third
meeting of the Advisory Council on
Blood Stem Cell Transplantation
(ACBSCT), Department of Health and
Human Services (HHS). The meeting
will be held from approximately 8:30
a.m. to 5 p.m. on December 15, 2008,
E:\FR\FM\04NON1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 214 (Tuesday, November 4, 2008)]
[Notices]
[Pages 65609-65610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26271]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, e-mail paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer on (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (b) the
accuracy of the agency's estimate of the burden of the proposed
collection of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: Enrollment and Re-Certification of Entities in the
340B Drug Pricing Program (NEW)
Section 602 of Public Law 102-585, the Veterans Health Care Act of
1992, enacted section 340B of the Public Health Service Act (PHS Act)
``Limitation on Prices of Drugs Purchased by Covered Entities.''
Section 340B provides that a manufacturer who sells covered outpatient
drugs to eligible entities must sign a pharmaceutical pricing agreement
with the Secretary of Health and Human Services in which the
manufacturer agrees to charge a price for covered outpatient drugs that
will not exceed an amount determined under a statutory formula.
Covered entities which choose to participate in the section 340B
Drug Pricing Program must comply with the requirements of 340B(a)(5) of
the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from
accepting a discount for a drug that would also generate a Medicaid
rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from
reselling or otherwise transferring a discounted drug to a person who
is not a patient of the entity.
In response to the statutory mandate of section 340B(a)(9) to
notify manufacturers of the identities of covered entities and the
mandate of section 340B(a)(5)(A)(ii) to establish a mechanism to ensure
against duplicate discounts and the ongoing
[[Page 65610]]
responsibility to administer the 340B Drug Pricing Program while
maintaining efficiency, transparency and integrity, the HRSA Office of
Pharmacy Affairs (OPA) developed a process of registration of covered
entities to enable it to address those mandates.
Enrollment/Registration
To enroll and certify the eligible federally funded grantees and
other safety net health care providers, OPA requires entities to submit
administrative information (e.g., shipping and billing arrangements,
Medicaid participation), certifying information and signatures from
appropriate grantee level or entity level authorizing officials and
state/local government representatives. The purpose of this
registration information is to determine eligibility for the 340B
program. This information is received and verified according to 340B
requirements and entered into the 340B database. Accurate records are
critical to implementation of the 340B legislation especially to
prevent diversion and duplicate discounts. To maintain accurate
records, the OPA requests entities to submit modifications to any
administrative information that they submitted when initially enrolling
into the program. The burden requirement for these processes is
minimal.
Recertification
The purposes of recertification are to request that 340B covered
entities annually certify program eligibility and confirm the accuracy
of all information in the covered entity's 340B database record.
Recertification is an electronic process that will require the covered
entity to review the current database record and submit required edits
(i.e., covered entity name and address changes, changes to 340B
designated contact information, billing and shipping arrangements). The
recertification process will pose a minimal burden to 340B covered
entities.
Contract Pharmacy Self-Certification
In order to ensure that drug manufacturers and drug wholesalers
recognize contract pharmacy arrangements, covered entities that elect
to utilize a contract pharmacy are required to submit to OPA a self-
certification form similar to the registration form that they have
signed an agreement with the contract pharmacy.
The estimates of annualized burden are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Reporting requirement respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
DSH & CHILDREN'S HOSPITAL ENROLLMENT, ADDITIONS & RECERTIFICATIONS
----------------------------------------------------------------------------------------------------------------
340B Program Registrations & 70 1 70 .25 17.5
Certifications for
Disproportionate Share
Hospitals......................
340B Program Registrations & 80 1 80 .25 20
Certifications for Children's
Hospitals......................
Certifications to Enroll DSH & 180 1 180 .083 14.94
Children's Hospitals Outpatient
facilities to 340B Program.....
DSH & Children's Hospitals' 937 1 937 .5 468.5
Annual Recertification.........
----------------------------------------------------------------------------------------------------------------
REGISTRATION FOR ENTITIES OTHER THAN HOSPITALS & RECERTIFICATIONS
----------------------------------------------------------------------------------------------------------------
340B Registration Form (Family 170 1 170 .083 14.11
Planning, STD, TB, and others).
Family Planning Annual 85 47 3995 .083 331.59
Recertification................
STD & TB Annual Recertification. 111 11 1221 .083 101.34
Other Entity Annual 400 10 4000 .083 332
Recertification for entities
other than DSHs, FP, STD or TB
entities.......................
Submission of Administrative 460 1 460 .083 38.18
Changes for any entity.........
----------------------------------------------------------------------------------------------------------------
CONTRACTED PHARMACY SERVICES REGISTRATION & RECERTIFICATIONS
----------------------------------------------------------------------------------------------------------------
Contracted Pharmacy Services 2000 1 2000 .083 166
Registration...................
----------------------------------------------------------------------------------------------------------------
TOTAL....................... * 4493 .............. 13,313 .............. 1504.16
----------------------------------------------------------------------------------------------------------------
* The total number of respondents may be overestimated since we are unable to avoid duplication of respondents
who submit information to the OPA over the course of participation in the 340B Drug Pricing Program, via the
initial registration process to any updates/modifications and enrolling contract pharmacies, if applicable, to
the recertification process.
E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: October 28, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E8-26271 Filed 11-3-08; 8:45 am]
BILLING CODE 4165-15-P
